Class 2 Device Recall RFMD TPiece

• Date Initiated by Firm: February 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 21, 2006
• Recall Number: Z-0579-04
• Recall Event ID: 28260
• Product Classification: Valve, Non-Rebreathing - Product Code CBP
• Product: RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea.
• Code Information: Catalog No. 395940, Lot numbers: 108273, 109600, 111314, 111229, 113984, 113932, 113931, 112991, 112514, 111588, 111589, 111558, 111557, 117867, 117866, 116471, 116163, 115616, 114992, 116865, 118714, 118055, 118054, 118053, 119421, 120628, 120521, 120021,120741, 120742, 122619, 122621, 122620, 123017, 123016, 123837, 126217, 125471, 125117, 124069, 126626, 126625, 127052, 127051, 128481, 128322, 127549, 127550, 129360, 129109, 129991, 130186, 130187.
• Recalling Firm/ Manufacturer: Rusch Inc; 2450 Meadowbrook Pkwy; Duluth GA 30096-4635
• For Additional Information Contact: William Slevin; 770-623-0816
• Manufacturer Reason for Recall: Valve cap may become loose and enter the air circuitry.
• FDA Determined Cause: Other
• Action: Consignees were notified on 2/3/2004 via certified mail and telephone.
• Quantity in Commerce: 13560 pieces
• Distribution: Nationwide and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.